Medical Director - Contrast Media & Molecular Imaging

GE HealthCare

Multiple Locations

Job Description Summary

In this role you will join our R&D department for Pharmaceutical Diagnostics. You will lead the clinical development strategy and be responsible for designing and executing clinical development plans for MR Imaging assigned contrast agents. As such, you will have extensive cross-functional interaction within the company, ranging from pre-clinical through to clinical, regulatory and commercial functions worldwide.

Job Description

Responsibilities

To provide MRI clinical leadership in cross-functional projects and product/project teams;
To be responsible for the development and validation of the overall medical strategy of the assigned product(s) with appropriate internal or external experts, and for the agreement on this strategy with the appropriate internal business stakeholders;
To be responsible that project activities are planned, agreed and executed according to the milestones and the overall clinical development plan (it includes pre- and post-marketing activities);
To be responsible for the timely and accurate completion of project documentation such as protocols, amendments, case report forms and study reports;
To collaborate closely with the study team members to ensure a timely execution of the approved clinical studies;
To verify scientific accuracy of safety and efficacy summaries for regulatory/commercial purposes and to assist with the clinical sections of regulatory dossiers and or product specific scientific discussion, depending on pre- or post-marketing activities;
To work closely with the Risk Management, Compliance, Regulatory Affairs, Pharmacovigilance, Health Economic and Medical Affairs teams to establish and maintain strong risk assessment and management processes for decision making;
To provide input into Risk Management reviews as it relates to patient safety, the performance of risk assessment in the design of clinical studies, and the interpretation of patient safety and risk in the post-market environment;
To collaborate with multiple functions for identifying and selecting innovative products for development;
To work with internal teams and external experts to design clinical development plan and to support clinical research strategies for regulatory approval, reimbursement and adoption through Integrated Evidence Generation Plan.

Qualifications

Medical Degree or equivalent;
Substantial experience in Pharmaceutical, Biotech, or Contract Research Organization leading to good understanding of Clinical and Industry development of drug products;
A proven experience in Clinical Imaging in Oncology or Neurology in both academia and industry will be appreciated;
Proven experience in Good Clinical Practice (GCP) Clinical trials;
Must be willing to travel as required;
Experience working with Microsoft office products (Word, Excel, PowerPoint, Outlook);
Post graduate training/specialization in MRI;
Experience in scientific publications/communications;
Experience in managing KOLs, external experts. Brings his/her own network of KOLs, external experts;
Excellent interpersonal and organizational communication and influencing skills;
Good team player with global mindset;
Experience in managing complex projects and/or across global regions desirable;
Customer savvy with business acumen;
Must be willing to travel as required;
Ability to work independently and with rigor;
Good process knowledge, experience, and skills.